Chronic Lymphocytic Leukemia Clinical Trial

A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Summary

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Relapsed or refractory Chronic Lymphocytic Leukemia and require treatment in opinion of investigator.
Eastern Cooperative Oncology Group (ECOG) <= 1.
Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.

Exclusion Criteria:

History or is clinically suspicious for cancer-related Central Nervous System disease.
Receipt of allogenic or autologous stem cell transplant.
Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT00481091

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 10 Locations for this study

See Locations Near You

Moores Cancer Center at UC San Diego /ID# 5566
La Jolla California, 92093, United States
Dana-Farber Cancer Institute /ID# 5547
Boston Massachusetts, 02215, United States
University of Nebraska Medical Center /ID# 12261
Omaha Nebraska, 68198, United States
North Shore University Hospital /ID# 12267
New Hyde Park New York, 11040, United States
University of Texas MD Anderson Cancer Center /ID# 5575
Houston Texas, 77030, United States
Northwest Medical Specialties - Tacoma /ID# 26428
Tacoma Washington, 98405, United States
Peter MacCallum Cancer Ctr /ID# 6583
Melbourne Victoria, 3000, Australia
The Royal Melbourne Hospital /ID# 5576
Parkville Victoria, 3050, Australia
Universitaetsklinikum Koeln /ID# 5924
Köln Nordrhein-Westfalen, 50937, Germany
Leicester Royal Infirmary /ID# 15081
Leicester England, LE1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT00481091

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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